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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04755556
Other study ID # IRB-UOL-FAHS/718-XI/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2020
Est. completion date December 6, 2020

Study information

Verified date February 2021
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children


Description:

Cerebral Palsy is one of the most common issue seen in pediatric rehabilitation .Home based intensive Bimanual training has proven to be one of the most effective rehabilitation training for improving motor. The study determines the effectiveness of routine physical therapy with or without home-based intensive bimanual training on coordination of hands and daily activities of daily living. A nine months randomized control trial was comprised of thirty children with unilateral spastic cerebral palsy aged between 4 to 7 years. One group received routine physical therapy and the other group received a goal specific bimanual training from their parents in their home setting for 3.5 hours per week for 6 weeks according to a modified set up. Follow up sessions were done at 6th week. Activities of daily living and coordination were measured using Pediatric motor log activity scale and ABILHAND respectively.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 6, 2020
Est. primary completion date December 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 7 Years
Eligibility Inclusion Criteria: - Spastic CP children - Both male and female - Age 4-7 years - Actively grasp of objects from table i.e., stuff toys, making blocks - One to one attention Exclusion Criteria: - Cognitive delays preventing the child from following two-step instructions - Health diagnoses unassociated with USCP. - Parents unable to commit to entire duration of intervention. - Visual difficulties preventing performance of intervention tasks.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
home based intensive bimanual training
Home Based Intensive Bimanual Training with Routine Physical Therapy bimanual training includes. functional activities play with ball, make a dough, make beads, make blocks .Routine Physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.
Routine Physical Therapy
Routine physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.

Locations

Country Name City State
Pakistan University of lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

He P, Chen G, Wang Z, Guo C, Zheng X. Children with motor impairment related to cerebral palsy: Prevalence, severity and concurrent impairments in China. J Paediatr Child Health. 2017 May;53(5):480-484. doi: 10.1111/jpc.13444. Epub 2017 Jan 17. — View Citation

Oskoui M, Coutinho F, Dykeman J, Jetté N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24. Review. Erratum in: Dev Med Child Neurol. 2016 Mar;58(3):316. — View Citation

Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01. Review. — View Citation

Trønnes H, Wilcox AJ, Lie RT, Markestad T, Moster D. Risk of cerebral palsy in relation to pregnancy disorders and preterm birth: a national cohort study. Dev Med Child Neurol. 2014 Aug;56(8):779-85. doi: 10.1111/dmcn.12430. Epub 2014 Mar 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ABILHAND hand coordination 6th week
Secondary Pediatric Motor Log Activity Scale Activity of Daily Living 6th week
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